MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN MRH M2 BASEPLATE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number UNK_LIM

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Date 09/27/2021

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

It has been reported : "revision of an gmrs distal femur/mrh tibia to a gmrs distal femur/ gmrs proximal tibia.This was a tibia only revision due to a loose mrh tibial component.Surgeon stated that bone quality at time of previous revision on 31/8/18 was v poor, and would have straight to a prox tibia if it was available at the time (which it was not).".

Event Description

It has been reported : "revision of an gmrs distal femur/mrh tibia to a gmrs distal femur/ gmrs proximal tibia.This was a tibia only revision due to a loose mrh tibial component.Surgeon stated that bone quality at time of previous revision on (b)(6) 2018 was v poor, and would have straight to a prox tibia if it was available at the time (which it was not).".

Manufacturer Narrative

Reported event: an event regarding loosening involving an unknown mrh baseplate was reported.The event was not confirmed.Method & results: product evaluation and results: the reported device was not returned however a photograph was provided for review.The photo presented a baseplate, stem and insert in an assembly form.There is excessive tissue / cement on the back of the baseplate.Nothing else remarkable can be identified based on the photo.Clinician review: a review of the provided medical information by a clinical consultant indicated: this inquiry reports the failure of a gmrs tibial component about 3 years postop.I cannot confirm that this event took place since there were no office notes, no preop xrays and no operation reports regarding the possible root cause of this event, i cannot determine it with certainty.If this took place causes of loosening are multifactorial including surgical factors, patient activity, and patient¿s size and activity factors.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient's knee was revised due to a loose mrh tibial component.The exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: UNKNOWN MRH M2 BASEPLATE
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 12677763
• MDR Text Key: 277921029
• Report Number: 0002249697-2021-01746
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_LIM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male